MAUDE Adverse Event Report: VERTOS MEDICAL INC. VERTOS MILD DEVICE KIT

Model Number MDK-0001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 04/16/2020

Event Type  Injury  

Event Description

A patient complained of lower back and buttock pain after undergoing a mild procedure on (b)(6) 2020.The patient was admitted to the hospital and diagnosed with an epidural hematoma and durotomy.A neurosurgeron performed a decompressive laminectomy from l2 thru l5 and evacuated the hematoma and repaired the durotomy.The patient was then discharged from the hospital.Upon follow-up, it was determined the patient needed additional surgery to repair a suspected csf leak.Without operative notes and location of the epidural needle it is unclear if the mild device or epidural needle caused the hematoma and durotomy.No follow-up information on the last surgical procedure and patient outcome was available at the time of this report.

• Brand Name: VERTOS MILD DEVICE KIT
• Type of Device: MILD DEVICE KIT
• Manufacturer (Section D): VERTOS MEDICAL INC.; 95 enterprise; ste 325; aliso viejo, ca
• Manufacturer (Section G): VERTOS MEDICAL INC.; 95 enterprise; ste 325; aliso viejo,
• Manufacturer Contact: troy williams ; 95 enterprise; ste 325; aliso viejo, ca ; 4274720
• MDR Report Key: 10093534
• MDR Text Key: 194952793
• Report Number: 3006450448-2020-00001
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: B235MDK00010
• UDI-Public: B235MDK00010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MDK-0001
• Device Catalogue Number: MDK-0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR